Guest Opinion: Don't buy all the Zohydro hysteria

Wednesday

Apr 9, 2014 at 3:08 PM

A much needed new pain drug, Zohydro, is a better version of the existing forms of hydrocodone (Vicodin, Norco). Zohydro has none of the acetaminophen that the other hydrocodone tablets contain, eliminating the risk to the liver and kidneys. For typical three times per day Vicodin/Norco patients, switching to Zohydro will save their kidneys from being assaulted with 30,000 mg per month of acetaminophen, 360,000 mg per year. Over years, acetaminophen greatly increases the risk of kidney failure, requiring dialysis.

Lawrence Robbins, M.D.

A much needed new pain drug, Zohydro, is a better version of the existing forms of hydrocodone (Vicodin, Norco). Zohydro has none of the acetaminophen that the other hydrocodone tablets contain, eliminating the risk to the liver and kidneys. For typical three times per day Vicodin/Norco patients, switching to Zohydro will save their kidneys from being assaulted with 30,000 mg per month of acetaminophen, 360,000 mg per year. Over years, acetaminophen greatly increases the risk of kidney failure, requiring dialysis.

In addition, Zohydro is long-acting, lasting 8 to 12 hours, much longer than the 2 to 4 hours for the current Vicodin and Norco versions. Zohydro will eliminate the withdrawal felt after 3 hours of a short-acting painkiller. Zohydro is highly controlled, difficult to obtain, and requires additional paperwork and a special prescription. The Zohydro company, Zogenix, is marketing the drug very conservatively. Only select physicians will be prescribing Zohydro. So far, so good.

Unfortunately, there has been an unwarranted firestorm of hysterical protest over Zohydro. On Feb. 26-27, just prior to the drug’s launch, multiple print, TV, and radio outlets ran pieces slamming the drug. Every review of Zohydro was negative. The only physicians interviewed were addiction specialists, who do not treat chronic pain. Incredibly, the media chose to omit the opinions of pain specialists and patients.

A number of media outlets used the exact same words to describe Zohydro, most likely obtaining their statements from information written by a competing drug company. This is a multibillion dollar class of drugs, and competing companies will gain hundreds of millions of dollars if Zohydro is withdrawn by the FDA. Some of the falsehoods perpetuated by the media were:

1. “Zohydro will kill people as soon as it is released.” (Nobody has died).

2. “Zohydro is 10 times stronger than Vicodin.” (It is the same strength).

3. “It only takes 1 or 2 tablets to kill a patient.” (Untrue).

4. “Children who take 1 pill will die.” (Unlikely, and how will a child have access?)

5. “This is the worst decision by the FDA, a disaster and tragedy for this country.” (It was the right decision).

6. “Zohydro is more powerful than anything on the market.” (It is actually the least powerful opioid in its class, when compared to oxycodone or morphine).

These statements, each more ridiculous than the last, were parroted by the media without any balanced opinion by an expert in pain medications.

A number of legislators, some who may have received Pharma money, have railed against Zohydro. U.S. Sen. Charles Schumer, D-N.Y., appealed to U.S. Health and Human Services Secretary Kathleen Sebelius to overrule the FDA. He appeared with someone who had lost a family member in a pharmacy robbery.

So, that is why we should ban Zohydro? U.S. Sen. Joe Manchin, D-W.Va, wanted Zohydro off the market, and he stated that this is “life or death for West Virginia!” His daughter happens to be the CEO of Mylan Labs, whose drugs include: morphine, oxycodone, and hydrocodone. Zohydro will take away market share from Mylan. New laws have been discussed, both statewide and nationally, to ban Zohydro. U.S. Rep. Stephen Lynch, D-Mass., introduced legislation surrounding Zohydro.

Gov. Deval Patrick actually prohibited Zohydro from being prescribed in his state. The governor of Vermont, Peter Shumlin, issued an “emergency order” rendering it more difficult to prescribe stronger painkillers, including Zohydro. These are deeply troubling actions, whereby politicians override the FDA experts.

Twenty-nine state attorneys generals have asked the FDA to overturn its decision. These attorneys generals prosecute drug crimes; they are not in the trenches with the suffering pain patients. Even Dr. Oz has jumped on the anti-Zohydro bandwagon.

Despite the intense pressure, the FDA has held its position, consistently defending the Zohydro decision.

There is a legitimate opioid abuse problem in this country. The use of Zohydro may actually decrease abuse, as it is longer-acting than the current hydrocodone versions. The opponents of Zohydro insist that it contain “abuse deterrent” technology, as if that is an answer to our opioid problem. “Abuse deterrent” drugs possess an extra ingredient, rendering it difficult to snort or inject the opioid. There is no evidence that this actually deters abuse, and these new formulations have increased side effects and costs.

Ninety-six percent of the overdoses with opioids occur when people ingest the medicine with alcohol and/or other sedatives. Only a few percent actually overdose by injection. We are punishing the tens of millions of legitimate chronic pain patients because of the small percentage of abusers.

Nothing good happens when uninformed lay people dictate our public health policy. In 2004 the U.S. Congress, along with the attorney general of New York, exerted intense pressure on the FDA to place a “black box” warning on antidepressants.

These warnings led to a decrease in the diagnosis of depression among youths, and ultimately correlated in increased suicides. More recently, Hollywood celebrity Jenny McCarthy led the anti-vaccine movement, which resulted in a dramatic increase in whooping cough, along with other preventable illnesses.

We desperately need better therapies for chronic pain, including medications and other treatments. Opioids are far from ideal, but for many with severe pain they greatly improve quality of life. Zohydro will be a good drug for many pain sufferers, without damaging their kidneys. Unfortunately, many in the media, along with certain legislators, are attempting to drive Zohydro off the market. That would be a tragedy.

Lawrence Robbins, M.D. is a neurologist and headache specialist near Chicago. He has written three books and 230 articles, mostly on pain and headache. Email doclarryrobbins@aol.com. Robbins notes that three years ago, he was a speaker for Zogenix. He says he has no financial interest in Zogenix.